Bariatric Surgery (Gastric Bypass)Phase 4NCT02374632
Gut Hormones as Mediators of Different Weight Loss Responses After Roux-en-Y Gastric Bypass
A Phase 4 study testing Meal tests after saline injection and Meal tests after octreotide injection in people with Bariatric Surgery (Gastric Bypass) and Severe Obesity, run by Hvidovre University Hospital at 1 site in Denmark.
Trial summary
After gastric bypass, 10-20% of patients will obtain a suboptimal weight loss, often defined as <50% of the excess body weight. Exaggerated meal related secretion of gut hormones seem important for appetite reduction and subsequent weight loss after gastric bypass, however it is not clear whether different gut hormone… Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Bariatric Surgery (Gastric Bypass), Severe Obesity
- What is being tested?
- Meal tests after saline injection and Meal tests after octreotide injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteDenmark
- Study dates
- Oct 2014to Jun 2017
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Uncomplicated primary Roux-en-Y gastric bypass >12 months ago
- Postoperative weight loss of >60%EBL or <50%EBL.
Who cannot join
- Inadequately treated thyroid disease
- Hemoglobin <6.5 mM
- Pregnancy or breastfeeding
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Department of Endocrinology, Hvidovre Hospital
Hvidovre, DK-2650
About this study
After gastric bypass, 10-20% of patients will obtain a suboptimal weight loss, often defined as <50% of the excess body weight. Exaggerated meal related secretion of gut hormones seem important for appetite reduction and subsequent weight loss after gastric bypass, however it is not clear whether different gut hormone responses are responsible for different postoperative weight loss responses. The purpose of the study is to investigate gut hormone secretion, vagal integrity and the effect of octreotide on ad libitum food intake in patients with suboptimal weight loss after gastric bypass and compare results to a matched group of gastric bypass operated patients with high postoperative weight loss but similar age, sex and preoperative BMI.
- Conditions
- Bariatric Surgery (Gastric Bypass), Severe Obesity
- Being tested
- Meal tests after saline injection, Meal tests after octreotide injection, Sham feeding
- Medical subject headings
- Obesity, Morbid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Meal tests after saline injectionOther
Fixed breakfast meal and ad libitum lunch meal
Meal tests after octreotide injectionOther
Fixed breakfast meal and ad libitum lunch meal
Sham feedingOther
| Study group | Role | What they receive |
|---|---|---|
| Low EBL | Other | Gastric bypass operated patients with low postoperative excess body weight loss (EBL) <50%.
Interventions: Meal tests after saline/octreotide injection in a randomized order, sham feeding. Receives: Other: Meal tests after saline injection; Other: Meal tests after octreotide injection; Other: Sham feeding |
| High EBL | Other | Gastric bypass operated patients with high postoperative excess body weight loss (EBL) >70% matched with respect to age, gender and preoperative BMI in the LowEBL group.
Interventions: Meal tests after saline/octreotide injection in a randomized order, sham feeding. Receives: Other: Meal tests after saline injection; Other: Meal tests after octreotide injection; Other: Sham feeding |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glucagon-like peptide-1 (GLP-1) secretion (Between groups difference in incremental Area-under-the curve (iAUC) GLP-1 after fixed breakfast meal on saline day)
Between groups difference in iAUC GLP-1 after fixed breakfast meal on saline day
Measured: 0-240 min
Peptide YY (PYY) secretion (Between groups difference in iAUC PYY after fixed breakfast meal on saline day)
Between groups difference in iAUC PYY after fixed breakfast meal on saline day
Measured: 0-240 min
Ghrelin secretion (Between groups difference in iAUC Ghrelin after fixed breakfast meal on saline day)
Between groups difference in iAUC Ghrelin after fixed breakfast meal on saline day
Measured: 0-240 min
Secondary outcomes (3)
Ad libitum food intake
Between groups difference in ad lib food intake
Measured: 240 min
Effect of octreotide on Ad libitum food intake (Between groups difference in %change in ad lib food intake between saline and octreotide day)
Between groups difference in %change in ad lib food intake between saline and octreotide day
Measured: 240 min
Vagal insufficiency (Between groups difference in % change in pancreatic polypeptide (PP) from fasting to early peak levels (15-30 min) after sham feeding)
Between groups difference in % change in PP from fasting to early peak levels (15-30 min) after sham feeding
Measured: 0-30 min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2015 (estimated)
- Study startOct 2014
- Primary completionDec 2016
- Study completionJun 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bariatric Surgery (Gastric Bypass)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hvidovre University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Copenhagen
- Responsible party
- Principal investigator, Kirstine Nyvold Bojsen-Moeller, Hvidovre University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02374632
- Sponsor's protocol ID
- KBM-R2-14
- Status last verified
- Feb 2017
- First submitted
- 17 Feb 2015
- Last updated
- 7 Feb 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gut Hormones as Mediators of Different Weight Loss Responses After Roux-en-Y Gastric Bypass
- ClinicalTrials.gov ID
- NCT02374632
- Acronym / sponsor ID
- KBM-R2-14
- Conditions
- Bariatric Surgery (Gastric Bypass), Severe Obesity
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Hvidovre University HospitalUniversity, hospital or other
- Collaborators
- University of Copenhagen
- Study start
- Oct 2014
- Primary completion
- Dec 2016 (actual)
- Study completion
- Jun 2017 (estimated)
- First posted
- 2 Mar 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
After gastric bypass, 10-20% of patients will obtain a suboptimal weight loss, often defined as <50% of the excess body weight. Exaggerated meal related secretion of gut hormones seem important for appetite reduction and subsequent weight loss after gastric bypass, however it is not clear whether different gut hormone responses are responsible for different postoperative weight loss responses. The purpose of the study is to investigate gut hormone secretion, vagal integrity and the effect of octreotide on ad libitum food intake in patients with suboptimal weight loss after gastric bypass and compare results to a matched group of gastric bypass operated patients with high postoperative weight loss but similar age, sex and preoperative BMI.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low EBL | Other | Other: Meal tests after saline injection, Other: Meal tests after octreotide injection, Other: Sham feedingGastric bypass operated patients with low postoperative excess body weight loss (EBL) <50%. Interventions: Meal tests after saline/octreotide injection in a randomized order, sham feeding. |
| High EBL | Other | Other: Meal tests after saline injection, Other: Meal tests after octreotide injection, Other: Sham feedingGastric bypass operated patients with high postoperative excess body weight loss (EBL) >70% matched with respect to age, gender and preoperative BMI in the LowEBL group. Interventions: Meal tests after saline/octreotide injection in a randomized order, sham feeding. |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Uncomplicated primary Roux-en-Y gastric bypass >12 months ago
- Postoperative weight loss of >60%EBL or <50%EBL.
Key exclusion criteria (3 listed)
- Inadequately treated thyroid disease
- Hemoglobin <6.5 mM
- Pregnancy or breastfeeding
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Meal tests after saline injectionFixed breakfast meal and ad libitum lunch meal | Other | High EBL, Low EBL |
| Meal tests after octreotide injectionFixed breakfast meal and ad libitum lunch meal | Other | High EBL, Low EBL |
| Sham feeding | Other | High EBL, Low EBL |
Primary outcome
Glucagon-like peptide-1 (GLP-1) secretion (Between groups difference in incremental Area-under-the curve (iAUC) GLP-1 after fixed breakfast meal on saline day)
Time frame: 0-240 min
Between groups difference in iAUC GLP-1 after fixed breakfast meal on saline day
Peptide YY (PYY) secretion (Between groups difference in iAUC PYY after fixed breakfast meal on saline day)
Time frame: 0-240 min
Between groups difference in iAUC PYY after fixed breakfast meal on saline day
Ghrelin secretion (Between groups difference in iAUC Ghrelin after fixed breakfast meal on saline day)
Time frame: 0-240 min
Between groups difference in iAUC Ghrelin after fixed breakfast meal on saline day
3 secondary outcomes
Ad libitum food intake
Time frame: 240 min
Effect of octreotide on Ad libitum food intake (Between groups difference in %change in ad lib food intake between saline and octreotide day)
Time frame: 240 min
Vagal insufficiency (Between groups difference in % change in pancreatic polypeptide (PP) from fasting to early peak levels (15-30 min) after sham feeding)
Time frame: 0-30 min
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Meal tests after saline injection and Meal tests after octreotide injection in people with Bariatric Surgery (Gastric Bypass) and Severe Obesity, run by Hvidovre University Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Glucagon-like peptide-1 (GLP-1) secretion (Between groups difference in incremental Area-under-the curve (iAUC) GLP-1 after fixed breakfast meal on saline day) (time frame: 0-240 min). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Feb 2017.